Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander

NCT ID: NCT04278846

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-22
• Study Completion Date: 2019-05-15

Brief Summary

Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. This information will be used to determine if liposomal bupivacaine provides better and longer pain control vs. bupivacaine HCl.

Detailed Description

Fifty consecutive (25 per arm) patients undergoing unilateral or bilateral breast reconstruction with tissue expanders will be administered intraoperatively in a standardized manner with either bupivicaine HCl (control group) or liposomal bupivacaine/Exparel (experimental group). Pain will be assessed qualitatively through the use of: 1) numeric rating scale during rest (NRS-R) and activity (NRS-A), 2) brief pain inventory (BPI) questionnaire, and 3) postoperative analgesia patient satisfaction scale. Furthermore, investigators will record the use of rescue analgesics for each patient. This part of the study will provide quantitative data that investigators can then use in comparison to the qualitative measurements (NSR, BPI, patient satisfaction scale rate). In turn, this will allow us to objectify patient's pain, thereby increasing the validity of our results. More importantly, this aspect of the investigation will enable us to study the impact that liposomal bupivacaine has in reducing the postoperative usage of opioid medications in this patient population. As this is a pilot study, a sample size of 50 total patients (25 per treatment group) is planned. This sample size should provide estimates of potential effect sizes and variability in the present setting to allow for future study planning. This study should provide adequate evidence of whether pain decreases of 15% or more are unlikely in this setting.

Investigators aim to evaluate the effectiveness of DepoFoam Bupivicaine (Exparel®) to reduce postoperative pain in breast reconstruction patients compared to the current standard treatment (bupivacaine HCl). Investigators hypothesize that patients undergoing breast reconstruction with tissue expander will achieve greater control of post-operative pain and longer lasting analgesia with the use of liposomal bupivacaine.

Conditions

Pain, Postoperative; Mammaplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DepoFoam bupivacaine

local anesthetic

Group Type: EXPERIMENTAL

Depofoam bupivacaine

Intervention Type: DRUG

The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Bupivacaine hydrochloride (HCl)

local anesthetic

Group Type: ACTIVE_COMPARATOR

Bupivacaine hydrochloride (HCl)

Intervention Type: DRUG

The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Interventions

Depofoam bupivacaine

The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Intervention Type: DRUG

Bupivacaine hydrochloride (HCl)

The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Intervention Type: DRUG

Other Intervention Names

liposomal bupivacaine, Exparel; Marcaine

Eligibility Criteria

Inclusion Criteria

• undergoing breast reconstruction with tissue expander

Exclusion Criteria

• history of adverse reaction to local anesthesia
• chronic liver disease
• history of chronic preoperative consumption of narcotics or opioids
• history of alcohol and/or illicit drug dependence
• undergoing combined procedures
• diagnosed with neuromuscular/neurosensory disorder
• positive pregnancy test
• previous breast conservation therapy (lumpectomy with radiation treatment
• previous surgeries or trauma in the breast or chest region (denervation may bias pain perception)
• axillary node dissection
• psychosis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Isakov, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-903

Identifier Type: -

Identifier Source: org_study_id